Vishal U Nair

• Involve and provide guidance for the Regulatory Strategies for NDA, LCM submissions and support the regional priorities by aligning with stakeholders
• Effectively managed the project on portfolio management of the Novo Nordisk products across the ROW markets
• Lead a digitalization project to build a tool on Regulatory Intelligence platform, where the tool has the national regulatory requirements and also the soft intelligence from the affiliates
• Completed a short term assignment for Regional Regulatory lead for Asia Pac for 4 months providing guidance on regulatory strategies to the affiliates
• Accomplished multiple tasks within established timeframes.
• Resolved team member conflicts, actively listening to concerns and finding appropriate middle ground.
• Cross-trained existing employees to maximize team agility and performance.
• Mentored junior team members for career advancement, fostering a pipeline of future leaders within the organization.
• Provide guidance and direction to Regulatory Affairs Team members and actively manage employee performance and development.

• Collaborated with cross-functional teams to ensure alignment on regulatory requirements and timelines.
• Enhanced regulatory compliance by developing and implementing effective policies and procedures.
• Prioritized project-related tasks to efficiently complete essential tasks.
• Performed and documented quality control checks to maintain compliance with company initiatives.
• Deliver and maintain license maintenance of the products registered in Europe and emerging markets mainly with Asia pacific region including driving regulatory strategy, ensuring regulatory compliance for defined product and project responsibilities
• Leading the Licence maintenance for MEA & EU region and act as a point of contact
• Supported the product life cycle projects like CDS update in reference markets, CMC variations, filing baseline applications for established products for LATAM & US region
• Responsible for preparation, review, and submission of Licence renewal packages/ submissions for APAC and other Emerging markets
• Cross functional discussion with product RAM and updating the licence renewal forecast for the products in scope along LR lead
• Handling of Health Authority questions and submitting the supplementary or subsequent responses for licence renewal submissions
• Collaborate and communicate with publishing and technical experts to ensure standard practices and quality submissions are met as per the timeline
• Handling of documents for acquirement and divestment projects, properties mapping and importing large amounts of documents to FirstDoc/ CARA, work with shared platforms
• Provided valuable insight in automation of the tools

• Develop or update project plans for Labeling project (USFDA), Policy 0070 Project (EU) & Clinical Trial Disclosure projects (EU) including information such as project objectives, tools used, systems, schedules, funding, and staffing.
• Support the team with the QC of the authored CCDS, PSUR’s, Redaction packages & the drafts of the results reported for the clinical studies in the EudraCT website and providing the client with the final submission package.
• Prepare project status reports by collecting, analyzing, and summarizing information and trends.
• Perform risk assessments in accordance with ICH Q9 Guideline.
• Preparation of Clinical Data Reports in accordance with EU Guidelines.
• Labeling project: CCDS/CCSI remediation – Authoring and life cycle management of CCDS/CCSI. Review of PSURs, Local labels from worldwide affiliates, Package inserts and do a gap assessment and provide client with the updated CCDS/CCSI which also includes the review of the PSURs
• Policy 0070 (Clinical Data Transparency): Preparation and submission of Redaction packages of Clinical Documents to EMA. Response to the queries raised by EMA on the Anonymisation report and the Justification tables provided along with the package.
• Clinical Trial Disclosure Project: Provide the information and report results for the Trial, Subject disposition, End point values, Adverse events from the Clinical Study Report into the EudraCT database.
• CMC Projects: Support Submission level authoring for ANDA, IND & IMPD submissions by doing gap analysis of the CMC documents.

• Submission of Dossier to various Semi-regulatory countries in CTD, ACTD and country specific formats.
• Variation filings for EU and ROW markets.
• Review of all project relevant documents like specifications, process validation, analytical method validation protocol & reports, stability protocols & reports etc. as per the regulatory requirements.
• Marketing authorization fillings and Life cycle management.
• Worked as a single point of contact for clients for all the projects.
• Quality Check of published output created by colleagues.
• Knowledge and working skills on Renewals and Variations for EU Markets.
• Uploading of administrative and technical documents on to the OTC Doc and Phoenix.
• Coordinate, Maintenance and revision of the events (Registration, Variation, Renewals) in OPAL.
• Deliver the projects within stringent timeline

Tools used: Insight Publisher, eRIMS (Register), Insight Validator, Smart Desk, OPAL, Register, Phoenix, OTC docs.

• Strategic Planning on execution part project-wise with the team members on the preparation of technical documents for registration and resolving queries for enabling business development in pharmaceutical markets (South East Asian Region).
• Registration & Re-registration for EU, LATAM & ROW.
• Software: RMS data management system, KAROMI for Artwork Management System
• Registration of Pharmaceutical products, Personal care products & Animal Health care products through online submission in countries like Malaysia & Singapore.
• Cross Functional Activities (Coordination with Quality Assurance & Quality Control, Formulation & Development, Clinical Team (Pharmacology), Production, Packaging Department, Marketing and design teams for timely Regulatory submission.
• Solving queries by regulatory authorities (MoH) and promptly replying in given time frame.
• Applying for Administrative documents, - Certificate of Pharmaceutical Product, Free Sale Certificate & Product Permission and legalizing the documents, from the concerned embassies.
• Clearance of Artworks, Change Control Forms etc., monitoring & maintenance of weekly overview of the projects.
• Preparation & Updating annual reports over the submissions & registrations.

• To maintain the existing business and to generate new corporate business for the Life science instruments in Pharmaceutical companies like Biocon, Aurigene, Syngene, etc.. in Karnataka region.
• To maintain the existing business and to generate new Institutional business for the Life science instruments in educational institutes like IISC, IIHR, National universities in Karnataka region.
• To meet Scientists, Research Scholars, generate enquiries for our products, analyze & understand their need, convenience them with team effort, get the order and maintain the relationship.

• To maintain the existing business and to generate new corporate business for the Life science Accessories in Pharmaceutical companies like Biocon, Hospira, Orchid chemicals, Shashun, Ranbaxy, Cipla etc.. in South India region.
• To provide the Filter validation services for the process filters for the pharmaceutical companies.
• To maintain the existing business and to generate new Institutional business for the Life science Accessories in educational institutes like IISC, IIHR, National universities in South India region.
• To meet Scientists, Research Scholars, generate enquiries for our products, analyse & understand their need, convenience them with team effort, get the order and maintain the relationship.

QC activities:

• Wet laboratory - Finished Goods, Raw Materials & Packing Materials (Sampling & Analysis).
• Internal calibrations of lab Instruments and glass wares.
• Reagents preparation & Standardization, SOP & Protocol Preparation, Market Complaint Handling.
• Sterility testing of the various spices & Spices products.
  

QA activities:

• Document control & updating, In-process checks.
• Action on Non-Conformance, COA preparation & HACCP.
• Maintaining documents and facing Audits and GMP.
• Maintaining 5S at working area.